A Phase 1 interventional study of Placebo and MEDI-570 0.03 MG in Lupus Erythematosus, Systemic, sponsored by MedImmune LLC. Terminated at 17 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-26.
Sponsored by MedImmune LLC · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate the safety and tolerability of MEDI-570 in adult subjects with moderately to severely active systemic lupus erythematosus (SLE).
This is a Phase 1, double-blind, randomized, placebo-controlled study to evaluate the safety and tolerability of escalating single subcutaneous doses of MEDI-570 in adult subjects with moderately to severely active SLE.
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's enrollment of 44 is below the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →MedImmune LLC is the lead sponsor of 265 studies on the registry; none are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 28 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
Other: Placebo
A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
Biological: MEDI-570 0.03 MG
A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
Biological: MEDI-570 0.1 MG
A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
Biological: MEDI-570 0.3 MG
A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
Biological: MEDI-570 1 MG
A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and Day 169 that were absent before treatment or that worsened relative to pretreatment state.
Time frame: Day 1 to Day 169
Pharmacokinetic Parameters for MEDI-570
Following pharmacokinetic parameters were to be evaluated by using non-compartmental analysis: t1/2 = terminal phase elimination half-life which is the time measured for the serum concentration to decrease by one half; tmax = time to maximum observed serum concentration; Cmax = maximum observed serum concentration; AUC (0-t) = area under the serum concentration-time curve from time 0 to last measurable concentration; AUC (0-infinity) = area under the serum concentration-time curve from time 0 to extrapolated infinite time obtained from AUC (0-t) plus AUC (t-infinity); Vz/F = apparent volume of distribution, which is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug; CL/F = apparent clearance which is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Time frame: Predose and postdose on Day 1; Day 3, 5, 8, 15, 29, 57, 85, 113, 141, and 169
Number of Participants With Anti-Drug Antibodies to MEDI-570 at Any Visit
Time frame: Predose on Day 1; Day 85, 113, and 169
| Milestone | Placebo | MEDI-570 0.03 MG | MEDI-570 0.1 MG | MEDI-570 0.3 MG | MEDI-570 1 MG |
|---|---|---|---|---|---|
| Started | 3 | 1 | 1 | 7 | 5 |
| Completed | 3 | 1 | 1 | 7 | 5 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and Day 169 that were absent before treatment or that worsened relative to pretreatment state.
| participants | Placebo | MEDI-570 0.03 MG | MEDI-570 0.1 MG | MEDI-570 0.3 MG | MEDI-570 1 MG |
|---|---|---|---|---|---|
| TEAEs | 3 | 1 | 1 | 7 | 4 |
| TESAEs | 0 | 0 | 1 | 2 | 0 |
Following pharmacokinetic parameters were to be evaluated by using non-compartmental analysis: t1/2 = terminal phase elimination half-life which is the time measured for the serum concentration to decrease by one half; tmax = time to maximum observed serum concentration; Cmax = maximum observed serum concentration; AUC (0-t) = area under the serum concentration-time curve from time 0 to last measurable concentration; AUC (0-infinity) = area under the serum concentration-time curve from time 0 to extrapolated infinite time obtained from AUC (0-t) plus AUC (t-infinity); Vz/F = apparent volume of distribution, which is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug; CL/F = apparent clearance which is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
No measurements were reported for this outcome.
| participants | Placebo | MEDI-570 0.03 MG | MEDI-570 0.1 MG | MEDI-570 0.3 MG | MEDI-570 1 MG |
|---|---|---|---|---|---|
| Number of Participants With Anti-Drug Antibodies to MEDI-570 at Any Visit | 0 | 0 | 0 | 1 | 1 |
Collected over Day 1 to Day 169. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/3 (0%) | 3/3 (100%) |
| MEDI-570 0.03 MG | — | 0/1 (0%) | 1/1 (100%) |
| MEDI-570 0.1 MG | — | 1/1 (100%) | 1/1 (100%) |
| MEDI-570 0.3 MG | — | 2/7 (28.6%) | 7/7 (100%) |
| MEDI-570 1 MG | — | 0/5 (0%) | 5/5 (100%) |
| Event | Placebo | MEDI-570 0.03 MG | MEDI-570 0.1 MG | MEDI-570 0.3 MG | MEDI-570 1 MG |
|---|---|---|---|---|---|
| CholelithiasisHepatobiliary disorders | 0/3 | 0/1 | 1/1 | 0/7 | 0/5 |
| Disseminated tuberculosisInfections and infestations | 0/3 | 0/1 | 0/1 | 1/7 | 0/5 |
| GastroenteritisInfections and infestations | 0/3 | 0/1 | 0/1 | 1/7 | 0/5 |
| Event | Placebo | MEDI-570 0.03 MG | MEDI-570 0.1 MG | MEDI-570 0.3 MG | MEDI-570 1 MG |
|---|---|---|---|---|---|
| Diastolic dysfunctionCardiac disorders | 0/3 | 0/1 | 1/1 | 0/7 | 0/5 |
| DiarrhoeaGastrointestinal disorders | 0/3 | 0/1 | 1/1 | 0/7 | 1/5 |
| Gastrointestinal ulcerGastrointestinal disorders | 0/3 | 0/1 | 1/1 | 0/7 | 0/5 |
| Oesophageal ulcerGastrointestinal disorders | 0/3 | 0/1 | 1/1 | 0/7 | 0/5 |
| CandidiasisInfections and infestations | 0/3 | 0/1 | 1/1 | 0/7 | 0/5 |
| SinusitisInfections and infestations | 0/3 | 1/1 | 0/1 | 1/7 | 0/5 |
| Alanine aminotransferase increasedInvestigations | 0/3 | 0/1 | 1/1 | 0/7 | 0/5 |
| Neck painMusculoskeletal and connective tissue disorders | 0/3 | 0/1 | 1/1 | 0/7 | 1/5 |
| HeadacheNervous system disorders | 0/3 | 0/1 | 1/1 | 3/7 | 2/5 |
| NephrolithiasisRenal and urinary disorders | 0/3 | 0/1 | 1/1 | 0/7 | 0/5 |
Safety population included all participants who were randomized into the study and received at least 1 dose of investigational product.
| Age, Continuous(years) | Placebo | MEDI-570 0.03 MG | MEDI-570 0.1 MG | MEDI-570 0.3 MG | MEDI-570 1 MG | Total |
|---|---|---|---|---|---|---|
| Mean | 38.3 ± 10.6 | 49.0 ± NA | 41.0 ± NA | 35.6 ± 22.2 | 39.6 ± 13.8 | 38.4 ± 16.1 |
| Sex: Female, Male(Participants) | Placebo | MEDI-570 0.03 MG | MEDI-570 0.1 MG | MEDI-570 0.3 MG | MEDI-570 1 MG | Total |
|---|---|---|---|---|---|---|
| Female | 3 | 1 | 1 | 6 | 5 | 16 |
| Male | 0 | 0 | 0 | 1 | 0 | 1 |
This study is terminated, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Lupus Erythematosus, Systemic→
MedImmune LLC